The European Commission has rejected Bulgaria’s proposed rules on pharmaceutical trade, which include a ban on rare medicine exports until domestic needs are fully covered.

Authorities in Sofia are trying to fight the parallel export of drugs, which leads to shortages in pharmacies and threatens the health of large groups of patients with chronic diseases, such as diabetes. Pharmaceutical traders achieve higher drug prices in other EU countries, with Bulgaria’s largest export country being Poland.

“The draft law raises concerns about the free movement of medicinal products within the internal market,” the European Commission’s position to the Bulgarian authorities says. It was made public on 21 March. Despite the negative notification from the Commission, the Bulgarian government, which is working while under resignation, believes that the law should be adopted.

The draft, proposed by the Ministry of Health, aims to change the formula for calculating the country’s shortage of medicinal products.

Falling below 65% threshold

Currently, Bulgarian authorities can impose a ban on the export of medicines when the quantities of a certain medicine fall below 65% of what is needed to satisfy domestic consumption for a period of one month.

The draft law changes the threshold from 65% to 100% of the necessary monthly quantities to cover the population’s health needs, which could stop the export.

As the commission explained to Sofia’s authorities, the EU Treaty prohibits the member states from imposing export restrictions.

“Export restriction measures can only be imposed if they are justified, necessary and proportionate to the pursued public goal, in this case guaranteeing the life and health of Bulgarian patients,” the Commission said.

Brussels called on Bulgaria to contact the European Medicines Agency (EMA) in the event of a critical shortage of medicines in order to use the European mechanisms for its management and mitigation.

During her visit to Bulgaria in November last year, the European Commissioner for Health, Stella Kyriakides, referred to the Commission’s Critical Medicines List of drugs in short supply in the European Union. A mechanism for voluntary solidarity sharing and exchange of medicines between member states is also set to help reduce medicine shortages.

Bulgaria insists on the ban

Despite the position of the Commission, the Ministry of Health in Sofia claims that the Parliament can continue the legislative procedure and accept the changes.

“The notification procedure does not provide for the issuance of a positive or negative opinion by the European Commission,” the Ministry of Health claims.

The Bulgarian government cites Directive (EU) 2015/1535, which introduces a three-month break in the legislative process if the Commission has objections.

A three-month period can be extended by another three months if the Commission or a member state makes a so-called “detailed opinion” expressing disagreement with the proposed texts. If no detailed opinions are received on the draft act after the expiration of the three-month deferral period, it can be adopted.

Blind dates – who blinked first?

The Bulgarian government claims that the Commission’s negative notification dates back to the end of 2023. Therefore, the three-month period has expired, which means that the procedure can continue.

Tackling the shortage of diabetes drugs and rare medicines has been a major concern for the Bulgarian authorities in the last few years. The shortage of medicines makes the Bulgarian government particularly sensitive during the negotiations on the new EU pharma legislation.

In response to Euractiv’s questions, the Bulgarian government announced that it is demanding that the EU pharma package introduce mechanisms to reduce drug prices in EU countries with a lower GDP than the EU average.

Pharmaceutical companies criticise the authorities in Sofia for introducing too many regulations, making the small Bulgarian market unattractive for business and leading to a further increase in drug shortages.

[By Krassen Nikolov, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]

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